(29 days)
Contour SE™ Microspheres are indicated for use for the embolization of hypervascular tumors and arteriovenous malformations.
The Contour SE TM Microspheres are spherical embolic particles and are available in a variety of particle sizes and are indicated for use for the embolization of hypervascular tumors and arteriovenous malformations. These particles are provided in a sterilized glass vial.
The provided documents are a 510(k) summary and an FDA clearance letter for Contour SETM Microspheres. These documents do not contain detailed acceptance criteria or a study that specifically "proves" the device meets acceptance criteria in the way a clinical trial report or a comprehensive validation study would for a new AI or diagnostic device.
Instead, this submission is for a medical device seeking substantial equivalence to existing predicate devices. Therefore, the "acceptance criteria" and "study" are focused on demonstrating that the new device is as safe and effective as legally marketed predicate devices, not on achieving specific performance metrics in a clinical context.
Here's a breakdown based on the information available:
1. Table of Acceptance Criteria and Reported Device Performance
The documents do not present a formal table of acceptance criteria with specific performance metrics (e.g., sensitivity, specificity, accuracy) like one would expect for an AI diagnostic tool. Instead, the "acceptance criteria" implicitly revolve around demonstrating biocompatibility and substantial equivalence to predicate devices. The "reported device performance" is essentially the finding of biocompatibility and substantial equivalence.
| Aspect of Acceptance Criteria | Reported Device Performance (from the document) |
|---|---|
| Biocompatibility | "The Contour SETM Microspheres have been tested for biocompatibility per ISO 10993. All data demonstrate this device is biocompatible for its intended use." |
| Substantial Equivalence | "The Contour SETM Microspheres have been tested and compared to the Summary of predicate device. All data gathered demonstrate this device as substantially equivalent. No new issues of safety or efficacy have been raised." |
| Intended Use | Indicated for "embolization of hypervascular tumors and arteriovenous malformations" (matches predicate devices). |
| Safety and Efficacy | Implicitly demonstrated through substantial equivalence to legally marketed predicate devices. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not specified in these documents. The testing for biocompatibility per ISO 10993 would involve specific sample sizes and protocols as defined by that standard, but the exact numbers are not detailed here. Similarly, the comparison to predicate devices would involve testing of the Contour SE™ Microspheres, but the "sample size" of devices tested is not provided.
- Data Provenance: Not explicitly stated regarding country of origin or retrospective/prospective. Biocompatibility testing is typically performed in laboratory settings. Given the nature of a 510(k) for a physical medical device, the "data" would primarily come from laboratory testing of the physical properties and biological interactions of the microspheres, and possibly from existing literature or data on the predicate devices.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This information is not applicable in the context of this 510(k) submission for a physical embolic device. "Ground truth" established by experts (like radiologists for image analysis) is relevant for diagnostic or AI devices, not for assessing the basic safety and performance of microspheres in a substantial equivalence pathway. The "ground truth" here is the scientific standards of biocompatibility (ISO 10993) and the established safety and efficacy of the predicate devices.
4. Adjudication Method for the Test Set
This is not applicable as it pertains to expert consensus on interpretation, which is not the primary assessment method for this device.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and effect size
No, a MRMC comparative effectiveness study was not done, and it would not be relevant for this type of device submission. MRMC studies are used for evaluating diagnostic performance, particularly of AI-assisted systems, comparing human reader performance with and without AI. This submission is for a physical embolic device.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
No, this is not an algorithm or AI device. Therefore, a standalone performance assessment in the context of computing algorithms is not applicable.
7. The Type of Ground Truth Used
For biocompatibility, the "ground truth" is adherence to the ISO 10993 series of standards, which are internationally recognized guidelines for evaluating the biological compatibility of medical devices. For substantial equivalence, the "ground truth" is established by comparing the device's characteristics (materials, design, performance, intended use) to those of legally marketed predicate devices that have already demonstrated safety and efficacy.
8. The Sample Size for the Training Set
Not Applicable. This is not an AI/ML device that requires a training set.
9. How the Ground Truth for the Training Set Was Established
Not Applicable. This is not an AI/ML device.
In summary:
The provided documents describe a 510(k) submission for a physical medical device (Contour SETM Microspheres) seeking clearance based on substantial equivalence to predicate devices. The "acceptance criteria" and "study" are framed around demonstrating biocompatibility according to ISO standards and showing that the device is as safe and effective as existing, legally marketed embolization devices. This is a different paradigm than what would be described for an AI-powered diagnostic tool, which typically involves detailed performance metrics, test sets, expert ground truth, and comparative effectiveness studies.
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Contour SET™ Microspheres – Sub S00 Siles
Contour SET™ Microspheres – Sub S00 Sizes
August 14, 2003
510(k) Summary K032542
| GeneralProvisions | Trade Name: Contour SETM Microspheres | ||
|---|---|---|---|
| Classification Name: Artificial Embolization Device | |||
| DeviceDescription/Indications forUse | The Contour SE TM Microspheres are spherical embolic particles and areavailable in a variety of particle sizes and are indicated for use for theembolization of hypervascular tumors and arteriovenous malformations.These particles are provided in a sterilized glass vial. | ||
| Data SummaryPrepared | September 15, 2003 | ||
| Contact Name/Number | Jodi Lynn GreenizenRegulatory Affairs Project ManagerBoston Scientific Corporation10 Glens Falls Technical ParkGlens Falls, NY 12801 | ||
| Name ofPredicateDevices | Contour® Emboli PVAEmbosphere MicrospheresEmboGold Microspehers | ||
| Classification | Class III, 21 CFR 882.5950Submitted Per 21 CFR 807 | ||
| PerformanceStandards | Performance Standards have not been established by FDA under Section 514of the Food, Drug and Cosmetic Act | ||
| Intended Useand DeviceDescription | Contour SETM Microspheres are indicated for use for the embolization ofhypervascular tumors and arteriovenous malformations. |
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2/2/ 1032542
Special 510(k) Contour SE™ Microspheres - Sub 500 Sizes August 14, 2003
| Biocompatibility | The Contour SE™ Microspheres have been tested for biocompatibility perISO 10993. All data demonstrate this device is biocompatible for its intendeduse. |
|---|---|
| ------------------ | ----------------------------------------------------------------------------------------------------------------------------------------------------------------- |
The Contour SE™ Microspheres have been tested and compared to the Summary of predicate device. All data gathered demonstrate this device as substantially Substantial Equivalence equivalent. No new issues of safety or efficacy have been raised.
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three overlapping human profiles facing to the right, with flowing lines suggesting movement or progress.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP 1 6 2003
Ms. Jodi Lynn Greenizen Regulatory Affairs Project Manager Boston Scientific Corporation 10 Glens Falls Technical Park Dix Avenue Glens Falls, New York 12885-3864
Re: K032542
Trade/Device Name: Contour SETM Microspheres Regulation Number: 21 CFR 882.5950 Regulation Name: Artificial Embolization Device Regulatory Class: III Product Code: HCG Dated: August 14, 2003 Received: August 18, 2003
Dear: Ms. Greenizen:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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Page 2 – Ms. Jodi Lynn Greenizen
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (301) 594-4659. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely vours.
Miriam C. Provost
Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications For Use
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・・・・
| 510(k) Number (if known) | -Unknown |
|---|---|
| Device Name: | Contour SE™ Microspheres |
| Indications for Use | Contour SE™ Microspheres are indicated for use for the embolization of hypervascular tumors and arteriovenous malformations. |
(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| Prescription Use | X | OR | Over-The Counter Use | |
|---|---|---|---|---|
| (Per 21 CFR 801.109) | (Optional Format 1-2-96) |
Miriam C. Provost
(Division Sign-Off)
Division of General, Restorative
and Neurological Devices
| Boston Scientific Corporation | 510(k) Number | K032542 |
|---|---|---|
| ------------------------------- | --------------- | --------------------------------------------------------------------------------------------- |
000066
§ 882.5950 Neurovascular embolization device.
(a)
Identification. A neurovascular embolization device is an intravascular implant intended to permanently occlude blood flow to cerebral aneurysms and cerebral ateriovenous malformations. This does not include cyanoacrylates and other embolic agents, which act by polymerization or precipitation. Embolization devices used in other vascular applications are also not included in this classification, see § 870.3300.(b)
Classification. Class II (special controls.) The special control for this device is the FDA guidance document entitled “Class II Special Controls Guidance Document: Vascular and Neurovascular Embolization Devices.” For availability of this guidance document, see § 882.1(e).